DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Regarding claim 1, the claim is indefinite because it is unclear if the claim positively claiming the combination of the holding structure and the primary packaging containers, or the sub-combination of the holding structure alone. For example, the preamble of the claim, “A holding structure for concurrently holding a plurality of primary packaging containers” is clear that the primary packaging containers are not positively recited and only the intended use of the holding structure with the capability of carrying the primary packaging containers is required. However, in lines 20-21 of the claim, language of “a primary packaging container accommodated in the receptacle in a resting position is tilted by an angle of not more than 2.4 degrees” appears that the primary packaging containers are positively required because the claim positively recites the primary packaging containers are tilted when accommodated in the receptacles. Claims 2-10 inherits the same issue of claim 1 because either the claims are dependent on claim 1 and/or the claims has the structure recited in claim 1. For prior art and rejection purposes, the examiner considers that the primary packaging containers are not recited as part of the claimed invention, but only the capability of the holding structure and the receptacles to receive the primary packaging containers is required. Regarding claim 8, language reciting “in each receptacle there are one more positions” is indefinite because it is unclear if applicant is referring to “one or more positions”, or what applicant meant by “one more positions”? Clarification of this issue is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 5 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Komann (US 2020/0156824).
Claim 1
Komann discloses a holding structure (1) capable concurrently holding a plurality of primary packaging containers for substances for pharmaceutical, medical or cosmetic applications (see [0022]), each primary packaging container could include an elongated cylindrical body region having a container longitudinal axis running in a container longitudinal direction through a center of the elongated cylindrical body region, the holding structure comprising a plurality of receptacles (5) capable of accommodating at least a section of the elongated cylindrical body region of the primary packaging container, each receptacle having a depth, an upper/top end capable of inserting the primary packaging container into the receptacle, a bottom end having a holding portion (22) configured to limit an axial movement of the primary packaging container in the receptacle, a circumferentially formed side wall (10) extending in a longitudinal direction from the upper end to the bottom end and a longitudinal axis running in the longitudinal direction through a center of the receptacle (see figure 1D); alignment elements (18) in each receptacle projecting radially into the receptacle and adapted and arranged to contact a part of the outer surface of the elongated cylindrical body region of a primary packaging container accommodated in the receptacle (see figure 1D); wherein the alignment elements in each receptacle are capable and arranged to contact a part of the outer surface of the elongated cylindrical body region (see figure 1D) in such a way that a primary packaging container accommodated in the receptacle in a resting position could be tilted by an angle of not more than 2.4 degrees, the angle being formed between the longitudinal axis and the container longitudinal axis and the resting position being a position where the holding portion limits the axial movement of the primary packaging container accommodated in the in the receptacle. Komann discloses the receptacles of the holding structure is used to accommodate cylindrical containers. Depending on the diameter of the container, i.e. a container different than the container shown by Komann, the container would be able to tilt the not more than the required angle.
Claim 2
Komann further discloses the alignment elements in each receptacle are capable and arranged to contact a part of the outer surface of the elongated cylindrical body region in such a way that a primary packaging container accommodated in the receptacle in a lifting position could be still tilted by a lifted tilting angle of not more than 2.4 degrees, the lifted tilting angle being formed between the longitudinal axis and the container longitudinal axis of the primary packaging container accommodated in the receptacle and the lifting position could being where the primary packaging container is lifted out of the resting position in a direction away from the bottom end to a lifting height 10 to 50 % of the depth of the receptacle.
Claim 5
Komann further discloses the receptacles are arranged in a regular arrangement, an upper side (2) of the holding structure is formed as a plate-shaped carrier element, and
the receptacles project vertically from the plate-shaped carrier element (see figure 1A); wherein the side wall is formed as a common partition between each two directly adjacent receptacles of the plurality of receptacles (see figures 1A-1C).
Claim 6
Komann further discloses in each receptacle the alignment elements include a plurality of longitudinal alignment elements running in a longitudinal direction from the upper end to the bottom end of the receptacle and extending over at least 50% of an entirety of the depth of the receptable (see figure 1D).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Komann (US 2020/0156824) as applied to claim 1 above, and further in view of Deutschle (US 2015/0183541).
Komann discloses the holding structure formed by injection molding from plastic material (see [0052] and [0062]), wherein the sidewalls project at right angle from upper side of the holding structure. Komann does not disclose the side walls of the receptacles are inclined at a draft angle in relation to the longitudinal axis, as required. However, Deutschle discloses a packaging structure (30) comprising receptacles (34) each for receiving a single container (2), wherein sidewalls (32) of the receptacles are inclined at a draft angle in relation to a longitudinal axis so that an inner diameter of the receptacle constantly increases from bottom end to upper end (see figure 4b). It would
have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Komann having the sidewall inclined from bottom to top end of the receptacle as taught by Deutschle for easy insertion of the primary containers into the receptacles of the holding structure.
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Komann (US 2020/0156824) as applied to claim 1 above, and further in view of Komann (US 2022/0096732).
Claims 8 and 9
Komann further discloses each receptacle there are one or more position where at least two alignment elements are provided (see figure 1D). Komann does not disclose the alignment elements are adapted and arranged to punctually contact the outer surface of the primary packaging container on at least the part of the elongated cylindrical body region accommodated in the receptacle; or the alignment elements are located at a top of the side walls. Komann ‘732 discloses a holding device (101) for receiving a container (103), wherein the holding device comprising holding elements (401 or 402) adapted and arranged to punctually contact the outer surface of the container on at least the part of a body region accommodated in the receptacle; or the alignment elements are located at a top of side walls of the receptacle (figures 5A and 5B). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Komann replacing the alignment elements for the alignment elements of Komann ‘732 since simple replacement of one alignment for another is within the knowledge of an ordinary artisan in the art and would yield predictable results.
Allowable Subject Matter
Claims 11-14 are allowed. No prior art discloses a holding structure comprising primary packaging containers accommodated in a receptacle in resting position, wherein the primary packaging containers are tilted by an angle no more than 2.4 degrees.
Conclusion
Examiner has cited particular paragraphs and/or columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested of the applicant, in preparing responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or prior art(s) disclosed by the Examiner (in the attached PTO-892 form).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAFAEL A. ORTIZ whose telephone number is (571)270-5240. The examiner can normally be reached Monday - Friday 9am - 6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Orlando E. Aviles can be reached at 571-270-5531. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RAFAEL A. ORTIZ
Primary Examiner
Art Unit 3736
/RAFAEL A ORTIZ/Primary Examiner, Art Unit 3736
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